دورية أكاديمية
Round Robin Study for Evaluation an in vitro skin irritation test for medical device extracts using KeraSkin TM in Korea.
| العنوان: | Round Robin Study for Evaluation an in vitro skin irritation test for medical device extracts using KeraSkin TM in Korea. |
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| المؤلفون: | Kim J; Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety (MFDS), 187, Osongsaengmyong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungbuk, 28157, Republic of Korea. Electronic address: kjh074@korea.kr., Kang NH; Korean Center for the Validation of Alternative Methods (KoCVAM), National Institute of Food and Drug Safety Evaluation (NIFDS), Ministry of Food and Drug Safety (MFDS), 187, Osongsaengmyong 2-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungbuk, 28157, Republic of Korea., Kim JS; Korea Conformity Labotratories (KCL), 20, Bodeum 3-ro, Seo-gu, Inchen, Republic of Korea., Kim IS; Korea Testing & Research Institute (KTR), 12-63, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do, Republic of Korea., Kim Y; Korea Institute of Toxicology, 141, Gajeong-ro, Yuseong-gu, Daejeon, Republic of Korea. |
| المصدر: | Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association [Food Chem Toxicol] 2024 Oct; Vol. 192, pp. 114942. Date of Electronic Publication: 2024 Aug 18. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Ltd Country of Publication: England NLM ID: 8207483 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-6351 (Electronic) Linking ISSN: 02786915 NLM ISO Abbreviation: Food Chem Toxicol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Exeter : Elsevier Science Ltd Original Publication: Oxford ; New York : Pergamon Press, c1982- |
| مواضيع طبية MeSH: | Skin Irritancy Tests*/methods , Equipment and Supplies*/adverse effects , Irritants*/toxicity, Humans ; Republic of Korea ; Animal Testing Alternatives/methods ; Reproducibility of Results ; Epidermis/drug effects |
| مستخلص: | With the growing importance of alternative test methods that implement the 3Rs principles (Reduction, Refinement and Replacement) and the global importance of biological safety assessment data for medical devices is increasing. We have developed and optimized the 'KeraSkin™ Skin Irritation Test (KeraSkin™ SIT) for medical device' for regulatory application in biological evaluation according to ISO 10993-23. We conducted a round robin study to optimize and evaluate the performance of KeraSkin™ SIT for medical devices using KeraSkin™ Reconstructed Human Epidermis (RhE), which is developed and manufactured in Korea. This round robin study was performed to assess the transferability, reproducibility (within and between laboratories) and predictive capacity in 1 lead laboratory and 3 participating laboratories based on OECD Guidance Document 34. The predictive capacity, the results showed 83.3 % of sensitivity, 100 % of specificity and 91.6 % of accuracy. In conclusion, the results demonstrate that 'KeraSkin™ SIT for medical device' provides a robust test method for detecting irritant activity of medical device extracts and can be utilized for identifying low levels of potent irritants in medical device extracts. Therefore, it fulfills the requirements to be included as a 'me-too' test method to EpiDerm™ and SkinEthic™ skin irritation test in ISO 10993-23. Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Joohwan Kim reports financial support was provided by Ministry of Food and Drug Safety. Nam-Hee Kang reports financial support was provided by Ministry of Food and Drug Safety. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2024 Elsevier Ltd. All rights reserved.) |
| فهرسة مساهمة: | Keywords: ISO 10993-23; KeraSkin™; Medical device; Reconstructed human epidermis (RhE); Skin irritation |
| المشرفين على المادة: | 0 (Irritants) |
| تواريخ الأحداث: | Date Created: 20240820 Date Completed: 20240907 Latest Revision: 20240907 |
| رمز التحديث: | 20240908 |
| DOI: | 10.1016/j.fct.2024.114942 |
| PMID: | 39163915 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-6351 |
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| DOI: | 10.1016/j.fct.2024.114942 |